Lord Rooker: My Lords, officials from my department recently met contractors from University College London and the Veterinary Products Committee's medical and scientific panel to discuss concerns about the scientific viability of the project. We have recently received, on 20 October, the panel's written appraisal of the contractor's proposed approach. A decision will be taken once the advice has been considered.

Lord Tyler: My Lords, I am grateful to the Minister for that reply, but I am sure that he is aware that the hundreds of victims of organophosphate poisoning will be disappointed at the lack of progress.
	As I hope the Minister is also aware, successive Ministers in successive Governments have constantly said to these unfortunate people that more research is needed. Can he explain why this has been drawn out for so long? In particular, why have the concerns been raised at this late stage in this important study by UCL? Why were they not raised much earlier? Finally and most importantly, can the Minister really accept that the misery of the many organophosphate victims is less important than the millions that have been made by multi-national chemical companies? Which side are the Government on?

Viscount Ullswater: My Lords, does the Minister not agree that the conclusions reached at these meetings influence the work of the Commission? Is it right, therefore, that small groups should have such an influence on the whole of the EU, now of 25 members? Perhaps I should say that I sat on that committee and obviously contributed to the report.

Lord Avebury: My Lords, I also declare an interest as a member of the committee to which the noble Viscount referred. At the meeting in Stratford, will any proposals be made on the important subjects of counterterrorism, organised crime and migration? The account in the Guardian this morning says that carousel fraud is also being discussed. Will proposals be put to the G6 meeting at Stratford that could result in decisions by European Union bodies? If so, does the noble Baroness not agree that there has to be proper consultation with the other 19 states, otherwise such meetings could turn into a harmful device for the Union of Europe as a whole because the other 19 will feel excluded from that process?

Lord Bassam of Brighton: My Lords, we return to familiar territory and a debate which the noble Lords, Lord Goodhart and Lord Norton of Louth, sponsored at an earlier stage of the Bill. Obviously, we have had time to reflect and give the matter further consideration. For an order to be laid under Clauses 1 or 2, the Minister must consider that it serves the purpose outlined in Clause 1(2) of,
	"removing or reducing any burden, or the overall burdens, resulting ... from ... legislation",
	or Clause 2(2) to secure that,
	"regulatory functions are exercised so as to comply with the [five] principles",
	of better regulation. The Minister must consider that any provision under Clause 1(1) or 2(1) that does not merely restate an enactment satisfies the preconditions in Clause 3(2) whenever they are relevant.
	The effect of this is not to reduce in any way the onus on the Minister to base his decisions on reasonable opinion. We contend that these tests are real ones because the Minister is under a public law duty to be reasonable when forming a view of whether or not the provisions of an order are within the terms of the order-making powers in Clauses 1 and 2 and meet the preconditions in Clause 3(2). The effect is, however, to retain what is in the Government's view the right balance between the judgment of the Minister and Parliament, and the power of the courts. The Government are firmly of the opinion that this balance is for Parliament to decide on the basis of detailed information submitted by the Minister regarding whether any proposed order will deliver appropriate regulatory reform and meets the preconditions in Clause 3, and for the courts to step in only in the unusual instance that a Minister has breached his public law duty to be reasonable in his opinion.
	In Committee the noble Lord, Lord Goodhart, acknowledged that it is well-established law that the Minister's opinion can be quashed by the courts if it is found to be irrational, and that argument has been repeated this morning. If this amendment were to stand part of the Bill, however, the courts could override both the Minister and Parliament about whether an order is for the purposes set out in Clauses 1 or 2 and meets the preconditions in Clause 3. The noble Lord, Lord Borrie, is not with us today, but in Committee he argued that this cannot be right, and in his words would,
	"elevate judicial accountability over political accountability. That would be quite inappropriate".—[Official Report, 3/7/06; col. 21.]
	I put it another way: it would subcontract out constitutional matters to the courts, and I ask simply whether that is the right policy approach.
	As the Delegated Powers and Regulatory Reform Committee appears to agree in its notable report on the Bill, the Government believe that the effect of the reference to ministerial opinions does not in any way weaken the requirement for the Minister's opinion to be reasonable and subject to rigorous challenge. It simply ensures that the detailed challenges and decisions over, for example, what constitutes a necessary protection in a particular case or how to balance the removal of an obstacle to productivity against an increase in financial costs for some are judgments which should be made only by a Minister, subject of course to Parliament's agreement. They should not themselves be matters on which the court can substitute the opinion of the Minister and Parliament with its own judgment. It seems to me as a Minister that this is right. It is appropriate that relevant parliamentary committees make judgments about whether a particular order meets these tests and, as the Commons Regulatory Reform Committee puts it, about matters some of which are essentially political, while the court should be empowered to do so only on extreme—to be reasonable and fair—and very rare occasions when the Minister may have disregarded the public law duty to be reasonable in his opinion. The courts should not be able to substitute the Minister's opinion with their own.
	Noble Lords asked in Committee whether there is any reason why this subjectivity is more significant now than in the Regulatory Reform Act 2001. The Government believe that there is a reason. The Minister, exercising the power under Clause 1, must now assess financial and economic issues, along with the rebalancing of costs based on risk analysis, for example. In this Bill we are now talking about economic, financial and other practical analyses of what constitutes a burden and what is proportionate inspection and enforcement rather than legal burdens which can be more readily identified by lawyers from the face of enactments as the 2001 Act required.
	It is not for lawyers or the courts to decide whether orders are intra vires. So retaining the subjective opinion is even more important to ensure that the right balance is maintained between on the one hand the judgment of the Minister and Parliament, and on the other, the power of the courts. The important preconditions in the Bill relating to necessary protections, rights and freedoms have of course been taken over from the 2001 Act. In each case the 2001 Act provides that an order could be made if the Minister making it is of the opinion that it did not remove necessary protections, rights or freedoms from people which they can rightly and reasonably expect to keep. The existing limitation on the order-making power in Section 3 of the 2001 Act concerning fair balance is also a matter on which the Minister is required to have the necessary opinion.
	Indeed, it is right that the preconditions in Clause 3(2) follow that precedent and are subjective. Whether or not the provision made by order, taken as a whole, strikes a fair balance between the public interest and the interests of anyone adversely affected by it is essentially, we argue, a matter of judgment; it is certainly not a matter of objective fact. It may also be worth noting that the 2001 Act permits the making of such consequential or transitional provision as the Minister thinks appropriate—a subjective test rightly mirrored by the subjective tests in Clause 1(8) and (7) of the Bill.
	Parliamentary committees can require an order to be subject to the super affirmative procedure, if it is not already, and can recommend that a Minister should make specific amendments. Ultimately, if Parliament's disagreement with the Minister's view is insurmountable, it has a statutory right to veto an order if it does not agree with the Minister's opinion. That is a powerful veto. The Government have also given an undertaking that they will not force through orders in the face of opposition from Parliament.
	These procedural safeguards further ensure that orders will not deliver inappropriate reform. We argue that it is for Parliament to hold us to account, not the courts. We think it is right that essentially political decisions on policy matters should be located there and not within the courts—but, of course, with the public law test of reasonableness firmly in place.
	For those reasons, and to protect the interests of Parliament, we argue that the noble Lord should withdraw the amendment.

Lord Bassam of Brighton: My Lords, the noble Lord, Lord Jenkins, explained to your Lordships' House as he saw it what the effect of the amendment would be. We understand it slightly differently from the noble Lord; we think that the amendment would make it possible to remove or reduce burdens only from those exercising regulatory functions. Burdens could be removed only from regulators. This would exclude cutting red tape for the regulated, businesses, small and medium-sized enterprises and others that make up the essential backbone of the UK economy, and the voluntary and the charitable organisations that contribute so much to society. The noble Lord, Lord Kingsland, says it is an elegant solution, but its effect would be quite widespread. The Government are committed to removing and reducing burdens from the regulated, not just from regulators. For those reasons, we have to resist the amendment.
	Perhaps the noble Lord has another effect in mind for the amendment. The intended effect may be to restrict the order-making power in Clause 1 so that burdens can be removed or reduced only if they result from the exercise of regulatory functions. If that is the intended effect, I would again want to resist the amendment for the following reasons. It would be a substantial and, in our view, arbitrary restriction on the order-making power in Clause 1, as it would be used to preclude the removal or reduction of burdens in legislation that did not result from the exercise of a regulatory function. For the purposes of the Bill Clause 32 defines regulatory functions, and I assure the House that there are areas of the law that impose burdens for those businesses—I mentioned voluntary and charitable organisations before—that do not result from the exercise of a regulatory function. That is illustrated by the fact that many of the legislative reforms made by the regulatory reform order under the 2001 Act, which have delivered substantial savings to the United Kingdom economy, would not have been possible if this amendment had applied.
	I give an example. The regulatory reform order, which removed a law dating from the 19th century that arbitrarily restricted professional and other groups from forming partnerships of more than 20 people, would not have been possible. That order was sought by stakeholders, passed by Parliament, led to savings of £10,000 per relevant partnership and contributed, in our view, to the competitiveness of the United Kingdom economy. This amendment would have precluded the delivery of the reform, because the burden on business did not result from the exercise of a regulatory function, but from 19th-century legislation.
	Another regulatory reform order, which modernised and streamlined procedures for renewing or terminating business tenancies, led to estimated savings to business of about £19 million a year, would also not be possible if Clause 1 were amended in the way the noble Lord, Lord Jenkins, suggests. Again, the reason for that is that the burden reduced resulted not from the exercise of a regulatory function but from legislation that imposed requirements no longer considered necessary.
	Looking to the future and the further reform identified as necessary to boost UK competitiveness, the Department for Trade and Industry hopes to repeal the Limited Partnerships Act 1907 and amend the Partnerships Act 1890, in order to provide much-needed clarity regarding the law on limited partnerships, which are the dominant investment vehicle used in the UK for venture capital and private equity investment funds. It is estimated that private equity investment accounts for 1.1 per cent of UK GDP, with businesses backed by private equity employing some 3 million people. Clarifying the law on limited partnerships is therefore expected to have a substantial and positive impact on investment capacity in the UK, and on the competitiveness of the economy as a whole.
	Business has sought this reform to ensure that limited partnerships remain attractive vehicles for venture capital investment in the UK in an increasingly competitive market. Businesses have told us that they believe these reforms will maintain the UK's pre-eminent position within Europe. The reform is likely to have a substantial and positive effect on our competitiveness, precisely the kind of reform orders we should be able to deliver. Yet the noble Lord's amendment would preclude any such reform, because again in this instance the burden is neither on a regulator nor from the exercise of a regulatory function, but the result of outdated legislation. If I have properly understood the intended effect of the amendment, such reforms, despite their clear benefit to our economy, would not be possible because they remove burdens arising from legislation and not from the exercise of a regulatory function or from a regulator.
	In summary, either of these restrictions would be arbitrary and would preclude a Minister from reducing or removing burdens that were sensible, desired and sought by business and by those in the voluntary and charitable sector. So, for those very practical, hard-nosed reasons, which could have a serious consequence if we were to go down this route, and notwithstanding the elegance of the amendment, I invite the noble Lord, Lord Jenkins, to withdraw it.

Baroness Hollis of Heigham: My Lords, local government is about the community of place; therefore local government is about local difference and diversity. If it is not, it is not local; and if it is not about local decision making, it is not local government. Otherwise it becomes a post box for central government decisions.
	As previous speakers have said, much awaits the Lyons report because local government needs adequate and independent financial resources. It also needs structures that are effective, transparent, accountable and inspire confidence—and it is on structures that I wish to comment.
	First, I shall make a couple of points on internal structures. I very much welcome the more permissive and pluralist tone of the White Paper. Like previous speakers, I, too, raise an eyebrow at elected mayors. There is nothing one could not do as a majority leader than one could in addition have done as mayor, except require the majority leader to persuade—and rightly so.
	I also favour annual elections rather than all out because I believe in incremental change rather than swings-of-the-pendulum change. But, again, I welcome the fact that this is a matter for local authority decision making and I welcome very much the tone of my noble friend's White Paper today. I still slightly regret the imposition of Westminster style cabinet government on local government committee structures rather than the introduction into Westminster of more effective committee styles because I wanted all of our community to own change and not just the cabinet of the majority party.
	Although much less apparent in this White Paper—again I am sure this is to do with the influence of my noble friend—there is still, none the less, the belief that politics has to be conducted in a very macho, male, adversarial style, that it is about conflict, leadership and cabinets, whereas many of us would prefer to talk about consensus, incremental change and committees. I do not think the change of language is necessarily wise. I also suspect that single-member wards—although, again, this is rightly a matter for local authorities—will probably see a reduction in the number of women counsellors, currently standing at 30 per cent. I would regret that. But, as I say, the White Paper is about a more pluralistic and consensual tone and it is to be welcomed.
	I also welcome the greater permissiveness and pluralism in terms of external structures. I do not think it is any secret that my own local authority, Norwich City Council, hopes very much to become a unitary authority. It was, for 600 years, a county borough until 1974 and would very much like to have the capacity to become, yet again, a unitary and competent authority. Why? Because of the three problems that most face authorities such as my own—the problems of economic regeneration, anti-social behaviour and so-called problem families, and increased longevity and its effect on social care. These problems cut across the current district and shire council—and very often the health service authority—divides. I want to see local authorities with the competence, in a holistic way, to deal with those issues.
	At the moment in my city, four different local authorities end up providing different bits of local authority services. How on earth does the local citizen voter and taxpayer know who does what, to what standard, at what cost and with what accountability? If they do not know and they cannot hold someone accountable, why should they bother to vote? If they do not bother to vote, we see the end of local government.

Baroness Andrews: Yes, my Lords, I can. The tone of the White Paper is proof of the fact that we bow to the expert and experienced response that local authorities give when they know what their communities need. I think that we would all agree with that.
	On my noble friend's last but one point, we will have to leave the question of funding until we have the Lyons paper in front of us. I am sure that we will have many a serious debate on the implications of whatever Sir Michael comes forward with.
	I very much welcome what my noble friend said about the power and scope of local councils and how we intend to build those up. We have to revitalise our democracy. The starting point is to make local councillors feel that there is nothing more honourable or effective than representing their wards and councils. The White Paper will have to do that in a big way.
	On the RDAs, we will come forward with worked-out plans for the cities and the city regions. When the previous Secretary of State went around the country, as the present one has, talking to cities and councils, it was about the city and its region and the way in which economic development spills over well beyond the city's boundaries. The strength of cities and rural areas show that in addition to the cities' capacity to grow and be creative and competitive, like our European competitors, the rural areas can benefit in their own special way.
	High-level authorities such as oversight and scrutiny committees will be able to call on the RDAs to explain themselves if they so choose, making them more accountable. They are one of the named partners. There is a clear relationship here; we do not intend to diminish the power or capacity of the RDAs. We expect them to work closely and in harmony with cities and city regions when we come forward with those proposals.

The Countess of Mar: My Lords, it was very easy to predict that the noble Lord, Lord Taverne, would pray against these regulations, for his views on homeopathy are well known. I declare my interest in that I use homeopathy for minor ailments and as preventive measures. I see a qualified homeopath if I have something a bit more complex and I see my GP if I feel that I need his intervention. I firmly believe that those of us who do not wish to clog up our doctors' surgeries with trivial complaints should be allowed to treat them in whatever way we wish so long as we are armed with accurate information.
	These regulations are the result of protracted and wide consultation. They iron out existing anomalies whereby homeopathic medicines that existed before 1971 can carry therapeutic indications on their labels while those registered subsequently cannot. The regulations bring homeopathic medicines into line with the 2005 legislation on "traditional-use" herbal medicines. The information provided is required to be accurate.
	Homeopathy is widely used by the general public, who will benefit by being able to choose remedies for minor, self-limiting ailments such as nausea, headache, and the common cold. While there have been no clinical trials for over-the-counter remedies such as cough expectorants, and their efficacy is refuted in the March 2006 51st edition of the British National Formulary, homeopathic medicines have been used for more than 200 years and there is wide bibliographic evidence to support their use and effectiveness. They are safe and, unlike many newly developed drugs for which strict testing is required, have never killed anyone. As the noble Lord, Lord Taverne, should know, the first principle of any therapy is, first of all, do no harm.
	The noble Lord complains that homeopathy is not evidence-based. His charity, Sense About Science, claims:
	"Evidence-based medicine has been a major public gain of the 20th century".
	I agree that it is essential to protect the public from powerful new drugs, as has been clearly demonstrated by the recent Northwick Park drug trial that nearly killed six healthy young men. But what about the case of the withdrawal of Vioxx, in which the drug, used to treat arthritis, has been estimated to be responsible for between 88,000 and 140,000 extra cases of serious coronary heart disease in the USA?
	The evidence base for many conventional medical treatments is still extremely weak. According to the recent British Medical Journal clinical evidence review of 2,404 conventional treatments, only 15 per cent were rated as beneficial, 22 per cent as likely to be beneficial, 7 per cent as a trade-off between benefits and harms, 5 per cent as unlikely to be beneficial, 4 per cent as likely to be ineffective or harmful, and 47 per cent of unknown effectiveness.
	Sense About Science claims that homeopathy is not "evidence-based medicine". This is utterly untrue. Despite a chronic underfunding of research, the effectiveness of homeopathy in many conditions is supported by randomised clinical trials including for childhood diarrhoea, hay-fever, post-operative ileus and osteoarthritis, all of which were the subject of meta-analyses with positive conclusions. It has proved effective with asthma, fibromyalgia, influenza, glue ear, side effects of radiotherapy or chemotherapy, pain, sprains, upper respiratory tract infections and vertigo—each of which has undergone at least two positive randomised control trials—as well as with anxiety, ADHD, CFS, IBS, migraine, PMS, seborrheic dermatitis and tissue trauma, each of which has been the subject of a single randomised control trial with positive results.
	In addition, the six-year study at the Bristol Homeopathic Hospital, part of the United Bristol Healthcare Trust and one of five NHS homeopathic hospitals in the UK, published in the Journal of Alternative and Complementary Medicine involved over 6,500 consecutive patients with chronic diseases. All were referred by their GP or hospital specialist and many had tried conventional medicine first. There is a group of patients for whom conventional chemical treatments either do not work or are contra-indicated. Many find homeopathy helpful. Over 70 per cent of the Bristol patients in this study reported positive health changes after homeopathic treatment.
	The noble Lord states that the rules for the regulation of medicines should not allow homeopathic products to make unsubstantiated health claims. Two hundred years of bibliographic evidence, provings and traditional use are not unsubstantiated health claims. A proving is a qualitative research study observing and recording the experience of a group of health subjects who experimentally take a particular drug. Contemporary, qualitative, narrative-based research methods, which are becoming increasingly accepted in conventional medicine, are very similar to the techniques used in homeopathic provings.
	It seems extraordinary to me that, when faced with a phenomenon like homeopathy which is shown to work, normally credible scientists discard all the findings of numerous scientists such as Preparata, Del Guidice, Kunio Yasue and Louis Rey. Professor Madeleine Ennis of Queen's University, Belfast, with a large pan-European research team led by Professor Roberfroid of the Catholic University, Louvain, set out to show that homeopathy and water memory were utter nonsense. This was an exercise conducted with extreme scientific rigour. The results obtained were statistically significant. This was put down to human error. Professor Ennis then applied an automated counting protocol to the figures. In the end, she had to concede that high dilutions of the active ingredients in homeopathic solutions worked, whether or not the active ingredient was present in the water. She is quoted as saying:
	"The results compel me to suspend my disbelief and to start searching for rational explanations for our findings".
	As is the way with the establishment that so readily dismisses evidence it does not like, the Royal Society attempted to debunk these results in a BBC2 "Horizon" programme. The experiment appeared on television but the findings were never published in a proper scientific journal, unlike Professor Ennis's research. The 1994 publication in the Lancet of the results of the double-blind placebo controlled studies conducted by Dr David Reilly in Glasgow, which showed that homeopathy worked for asthma, were accompanied by an editorial comment:
	"What could be more absurd than the notion that a substance is therapeutically active in dilutions so great that the patient is unlikely to receive a single molecule of it? Yes, the dilution principle of homeopathy is absurd; so the reason for any therapeutic effect presumably lies elsewhere".
	Perhaps the noble Lord, Lord Taverne, and his Sense About Science friends could be persuaded to suspend their disbelief for a while and, instead of looking for a biochemical answer, look for a nano-pharmacological or a bio-physical one. Quantum physics provides a tauntingly fascinating window on life and it may just be that, instead of opposing something that he does not understand, his eyes will be opened to a set of totally new concepts. I remind the noble Lord of a speech he made on 24 June 2004, at col. 323 in Hansard. He might recall that he was critical of radiation safety standards. In advocating the benefits of low doses of radiation he described an effect known as hormesis. The toxicological definition of hormesis is:
	"A dose response phenomenon characterised by a low dose stimulation, high dose inhibition, resulting in either a J-shaped or an inverted U-shaped dose response. A pollutant or toxin thus has the opposite effect in small doses than in large doses".
	If that is what the noble Lord believes, he should be well on the way to accepting the principles of homeopathy.
	I am glad that the Government have agreed to bring in these regulations. The range of products is limited to the treatment of relatively minor, self-limiting conditions. The regulations will bring uniformity to complementary medicinal labelling and provide consumers with informed choice. I ask the Minister to resist the Prayer of the noble Lord, Lord Taverne.

Baroness Barker: My Lords, it is always interesting to follow my noble friend Lord Taverne in a debate. I look forward to taking part in debates with him as he is not only an incredibly knowledgeable but a very passionate speaker.
	It is important not to lose sight of what we are talking about here. We are talking about remedies for minor self-limiting conditions, such as travel sickness and muscular pain. Most of the orthodox equivalents for those conditions would be over-the-counter medicines, which probably have efficacy rates that are equally contentious.
	It therefore seems to me that the principal matter we should address is the extent to which these products are deemed to be safe and the claims that are made about them. I agree with what my noble Lord, Lord Rees, said in his introduction, although perhaps not with his conclusions.
	My reading of the order before us is that an extensive process is set out by which product manufacturers are required to demonstrate safety. There is an inherent dilemma in the questions my noble friend Lord Taverne poses to the homeopathic world. While he dismisses their products as being ineffective and not scientifically proven, he then asks for scientific proof. I would imagine that those on the other side of the argument would point out that that is an impossible thing to ask. They cannot, and perhaps do not wish to, prove what they do in scientific terms. I am struck by the extent to which we have to try to keep a sense of equivalence in all of this. The noble Lord, Lord Turnberg, made an interesting point about the extent to which homeopathic remedies might make people present late for conventional treatment. The same accusation might well be levelled against conventional orthodox treatments of a minor nature. That is one of the difficulties we have.
	The principal question I want the Minister to answer is: what would have been the effect on public health and the health of individuals had this measure not been tabled and had the MRHA not set out the requirements that it has? Leading on from that, the key question for all of us is what the consequent marketing authorisations will be for these products. What claims will manufacturers be able to make for them? The phrase "for the relief of" has already been mentioned. That phrase is used by those whose products for treating minor conditions such as flu are of a more conventional nature. I am not sure that they are any more effective.
	It is important that we know precisely what the marketing authorisation will be. What statement will manufacturers be able to make as a result of their product meeting the regulations? That issue was mentioned in the papers that we have been given. I note that in the consultation on the regulations there seemed to be a body of opinion that a product which had been through this process could be marketed as an anthroposophic medicinal product. I sincerely hope that that is not the case as that would be highly misleading for the general public. If as a result of going through these processes, a statement can be made that a product is based on homeopathic assessment, that is fair and reasonable. It is accurate and does not claim to be done on a scientific basis.
	There is agreement—whether negative or positive—that on balance homeopathy does no harm. Certainly its efficacy is unproven. We need to be sure that the measure does not open the way for product manufacturers to take greater licence than they should on making efficacy claims for products and regarding the basis of those claims. If the noble Lord can answer those questions, I shall be content for the measure to proceed.

Lord Warner: My Lords, one of the great joys of being a Health Minister in this House is that I am treated to a wide range of views. I am often strongly encouraged to support rather conflicting views.
	I shall try to confine my remarks to making clear the Government's role in the regulation of homeopathic products and explaining the aims of the new national rules scheme, about which there may be some misunderstanding, given the remarks made in the debate. I bow to the professional knowledge of the noble Lord, Lord McColl, on which orifice to use for which medication.
	The use of homeopathic products in this country has a long tradition, as a result of which a wide range has been available and regulated in the UK for many years. Homeopathic products have, for example, been available in the NHS since its inception in 1948. Successive Governments have accepted that homeopathy has its place within the range of treatment options available to patients. That is a historical fact. This Government strongly believe that consumers in the UK should be free to make informed choices about their care, and that includes the freedom to choose homeopathic products. Whether such products are supplied and paid for by the NHS is, under current funding arrangements, for local NHS service providers and primary care trusts to decide. That is exactly the same system that was in place when the noble Lord, Lord Jenkin of Roding, was a distinguished Secretary of State for Health.
	These new regulations flow from new EU medicines legislation, but it is optional to member states whether they bring it in. This Government have chosen to introduce the new scheme because it will improve the regulation of these products in the UK while continuing to support the principle that consumers should have the right to choose to use them if they so wish. Apart from Denmark and France, we are the only EU country so far to have introduced this scheme that will improve the protection of consumers who choose to use such products, and we have acted in patients' interests, not in the promotion of commercial products.
	Because homeopathic products are different from conventional medicines, it is right that they are regulated differently. Their efficacy cannot be demonstrated in the same way as is required for conventional medicinal products to obtain a licence, but that does not mean that homeopathic products should not be available. Having listened to the debate, I am not entirely clear how such products could ever demonstrate efficacy if they were totally banned. That would be a challenging scientific proposition.
	The new national rules scheme that this Government have introduced provides an appropriate regulatory scheme that will improve how many current homeopathic products are regulated. The new scheme continues to give consumers assurances of quality of manufacture and of safety and will provide them with better information about the products available. It develops existing arrangements, which involve two types of registration. The first is for homeopathic products that were on the market when the Medicines Act came into force in 1971 which have product licences of right (PLRs). When these products were included in that scheme in 1971, producers were allowed to label their products to say what they could be used for. Many of those products are still on the market today.
	The second regime is called the simplified scheme, which was introduced in 1992, when the EU first produced legislation for homeopathic products. New products coming on to the market since then have had to comply with those EU rules or with all the rules for conventional medicines, which of course would require them to demonstrate efficacy through clinical trials. Homeopathic products clearly could not do that. Moreover, the scheme's products may not be labelled to say what they are for—that might be a disadvantage for users. In answer to the noble Baroness, Lady Barker, those existing regulations would continue if these new regulations were not introduced.
	The introduction of the new national rules scheme offers an alternative approach that will bring a number of benefits for patients. First, it will, for the first time since the PLR scheme in 1971, allow homeopathic products to be marketed with information to the consumer about what they can be used for. This will provide better information to the consumer and reduce the risk of confusion. We expect that some products currently authorised under the simplified scheme will be switched because they will, for the first time if they qualify, be allowed to be labelled as suitable for the relief of specified conditions. However, to qualify for authorisation under this scheme, the manufacturer has to show, from literature, that there is a tradition of use of that product for a particular purpose. So an evidence base is being used, although it may not satisfy everyone who has spoken.
	Secondly, homeopathic products authorised under the new national rules scheme are required to comply with all aspects of the conventional medicines regime, except the requirement to demonstrate efficacy through clinical trials. That will bring significant benefits: improved assurances of quality in manufacture, safety, the review of information given to consumers, and the requirement to submit regular safety reports to the regulator and to submit to inspections. All those elements should reassure consumers, as the measures will enhance safety for those who choose to use homeopathic products.
	Thirdly, and importantly, the new national rules scheme provides a possible regulatory home previously not available when we had only the simplified scheme or a full licence available for the products with product licences of right. The MHRA intends to review all the PLRs in the next seven years to ensure that they are of appropriate quality and safety. The MHRA will allow only products authorised under the new scheme to be labelled as suitable for the relief of minor symptoms or conditions—as the noble Baroness, Lady Barker, made clear—products that you would expect to see available on general sale in, for example, supermarkets.
	This measure, while maintaining consumers' freedom to choose to use homeopathic products, will ensure that such products are better regulated and provide more and better information to the consumer. Furthermore, a mandatory statement will be included in the pack instructing the patient to consult their doctor if symptoms persist. Again, that is a new measure that directs people towards conventional medicine if there is a problem.
	The Advisory Board on the Registration of Homeopathic Products, a committee established under the Medicines Act to advise Ministers on matters concerning homeopathic products, will be instrumental in providing advice on the indications for, and safety and quality of, products registered under the new scheme, and on the review and rationalisation of PLRs. In last year's review of the medicines advisory committee, the advisory board was given a new and enhanced role to advise the Government directly on matters relating to homeopathy. It is an independent committee whose membership includes homeopathic practitioners, people with a wide range of clinical expertise, including GPs, paediatricians, toxicologists and pharmacists.
	The noble Lord, Lord Taverne, suggested that the Government are bowing to commercial pressure from the homeopathic industry in introducing this scheme. This is absolutely not the case. I have had meetings with the homeopathic industry, and I do not think that it sees us in the light that has been described this afternoon.
	As I have explained, the Government believe that the new national rules scheme provides a significant opportunity to improve consumer information about the use of homeopathic medicinal products on the UK market while maintaining rigorous control over their quality and safety. That will be welcomed by consumers who choose to use those products for minor conditions or illnesses.
	Unfortunately, a number of remarks have been made about the MHRA. It is not in breach of its statutory duties, nor does it promote homeopathic products on behalf of the industry that sells them. Having worked with the MHRA as the Minister responsible for it for two years, I regard it as a distinguished public body that has done a great deal in this country to protect the public through the regulation of medicinal products in a scientific way. The MHRA has a role in not only authorising products on grounds of efficacy, but ensuring that safety and quality standards are maintained. It is not concerned purely with efficacy.
	We accept that this scheme does not provide any endorsement of clinical efficacy as happens with conventional medicines. It is not designed to replace the use of more conventional treatments, which is why it is restricted to products for the relief of minor conditions that do not require medical intervention. Central to our policy was the inclusion of a statement in the product literature advising patients to consult their doctor if symptoms persist. I believe that the scheme will enable consumers to make more informed choices about the use of homeopathic products, and the regulatory regime will ensure that standards of quality and safety are maintained in the production and use of homeopathic products.
	That stance in no way diminishes the Government's support for evidence-based medicine or for scientific research into new pharmaceutical products that benefit patients. We have done much as a Government to support science and research, and will continue to do so. Homeopathic products are, however, in a different category. Provided that such products are safe, properly manufactured and clearly labelled without making false claims, which they will be under the new national rules scheme, patients should not be denied access to them for the conditions to which they relate.
	A number of noble Lords, including my noble friend Lord Turnberg, raised the issue of NICE. The Government have no plans to refer homeopathic remedies to NICE at present. I gently draw noble Lords' attention to the fact that NICE has quite a few things on its plate at the moment, including many potentially life-saving drugs. However, there is nothing to stop the use of the yellow card scheme, authorised under the new national rules scheme, to be applied in respect of adverse effects to homeopathic products, as is the case with conventional medicines.
	I believe that this is an area where we have to regulate in the way that we have done but, in our view, we must not deny people the right to use these medicines when they are safe, manufactured to an appropriate quality and properly labelled. These are good regulations that should be on the statute book.

Lord Norton of Louth: My Lords, in supporting this amendment, I wish to reiterate two points that I made in Committee. It is important to stress the independence of the economic regulators and the fact that that independence is not achieved at the expense of accountability.
	Regulators have to explain and justify their actions. In the Constitution Committee's report The Regulatory State: Ensuring its Accountability, the point was made that regulators are subject to what was termed "360 degrees of accountability". They are answerable to a range of bodies, including Parliament. They are bound by statute and can be challenged if they exceed their powers. Stipulating the independence of regulators does not affect the powers of Ministers to determine policy.
	The importance of maintaining the independence of regulators has been variously stressed, including by the Government. In Committee, I quoted from the evidence submitted to the Constitution Committee by the Department of Trade and Industry. The department said that,
	"the independence of economic regulators from Government—insulating decisions from short term political factors—is a fundamental contributor to regulatory certainty and prerequisite for continuing to attract private finance to regulated sectors".
	There is thus a compelling case for protecting the independence of regulators—and to be seen to be so doing. That was the case that I advanced in Committee, and my amendment is designed to ring-fence that independence.
	I listened with care to the Minister's response in Committee. His reasons for opposing the amendment were twofold. One was that the provisions of the Bill did not create a new position. Regulatory reform orders under the 2001 Act could be used to change the functions of the economic regulators and the provisions of the Act, he argued, had not led to any uncertainty. The second point was that the provisions allowed for flexibility subject to parliamentary scrutiny.
	The first point I do not find compelling. I was a critic of the 2001 Act, and the fact of carrying over existing provisions is no commendation. It has not led to market uncertainty because the powers have not been used in a manner that is contentious. My fears about the provision are more apparent if I rephrase that and say that the powers have not yet been used in a manner that is contentious. If the order-making power were to be employed to try to limit the independence of regulators, it may be blocked by Parliament, but the damage would already have been done. If tried once, the potential is always there, and markets thereafter may be far more wary. The point that has been variously stressed, not least by my noble friend Lord Onslow, and which the Government appear to have difficulty in accepting, is that a Government cannot bind their successors.
	The other point developed by the Minister is essentially one of convenience. He cited an example affecting the FSA. I counsel against generalising from an N of one, which seems to have happened an awful lot in discussing this Bill. I am not sure that we should concede the general point of enabling primary legislation to be amended by secondary legislation because there is one example of that proving useful. The potential for creating even one case of misuse should concern us.
	The Minister's argument, which is at the heart of what I find worrying about the Bill, is that because circumstances change, there may be a case for changing the functions of the regulator and this could conveniently be done by secondary legislation. In other words, it is an admission that we did not get the legislation right the first time round. Had we done so, there would have been appropriate provision in the Act for amending regulatory functions. We need to think through what this may entail for the Government's approach to primary legislation in future.
	I revert to the point that I made earlier. I believe that it is important to protect the independence of regulators and to be seen to be doing so. That combined with my somewhat purist view of primary legislation means that I am very happy to support my noble friend's amendment.

Lord McKenzie of Luton: My Lords, this is the second amendment on economic regulators tabled by the noble Baroness, Lady Wilcox, and, as she acknowledged, it bears a close resemblance to the amendment on economic regulators tabled by the noble Lord, Lord Norton of Louth, and my noble friend Lord Berkeley. Despite the refinement of the noble Baroness's amendment, the Government remain of the opinion that an amendment on the independence of economic regulators is unnecessary. I set out the reasons for that in Committee, but I am happy to reiterate them for the benefit of noble Lords. We have reflected on that debate to see whether we can provide further assurance to noble Lords.
	As the noble Baroness, Lady Wilcox, stated in Committee, and as this amendment seeks to install within the Bill,
	"independence and jurisdiction ... are essential if we are to ensure that private investors will have sufficient confidence in the regulatory system".—[Official Report, 19/7/06; col. 1332.]
	I agree. This Government are ensuring private investment confidence, and the UK is seen by private investors as one of the best places for companies to start, invest, grow and expand. In fact, according to the recent OECD report, Trends and Recent Developments in Foreign Direct Investment, the UK was the world's largest recipient of inward foreign direct investment in 2005, attracting £91 billion of FDI, the largest inward direct investment ever recorded in the UK. Furthermore, the World Bank's Doing Business 2007 report ranked the UK sixth, out of 175, in the world and first in the EU for ease of doing business. These statistics alone should provide sufficient confidence to private investors. However, the question this House must ask is: did the Regulatory Reform Act 2001, from which the economic regulators were not excluded, impinge on their independence and jurisdiction? The answer is no.
	The House must also ask: did the 2001 Act deter private investment in the UK? Given the World Bank and OECD reports just mentioned, the answer would have to be: no. The noble Lord, Lord Norton of Louth, suggested that that was because the powers had not yet produced that impact, but I thought the argument was that their existence created the problem. The existence of those powers in 2001 has clearly not created the problem.
	Finally, one might then ask: will this Bill, once enacted, deter private investment, on the basis that investors will see the order-making powers as a potential power to disrupt the market? On the contrary, the order-making power gives confidence not just to the private but also the public and voluntary sectors that this Government are serious about reducing or removing unnecessary burdens on those sectors.
	Clause 1(3) makes explicit that one of the Bill's objectives is to remove obstacles to "efficiency, productivity or profitability". Given that the Government recognise that investment is one of the main drivers to productivity, they would be extremely unlikely to make, under this Bill, any proposal that would jeopardise productivity through pursuing proposals that would undermine investor confidence. Parliament would also be likely to take a dim view of any such proposal.
	This House should be asking itself: will this Bill, once enacted, provide an effective vehicle for cutting red tape? After two previous Acts I hope that this House can be confident in itself to reply in the affirmative.
	I was surprised by some of the debate in Committee, which seemed to suggest that, using this Bill, Ministers could amend the regulatory structure on a whim—for example, by removing the chairman of an economic regulator—and as though Parliament had no say whatever in the process. That concern is clearly behind proposed subsection (4) of the amendment.
	Noble Lords will of course be aware that this Bill has more stringent safeguards than the 2001 Act and includes an absolute and unrestricted right of veto for Parliament. Ministers cannot act on a whim. They will also be aware that every order is subject to a statutory consultation process, which requires the Minister to consult such organisations and persons that appear to be representative of interests substantially affected by the proposals, including any body, such as a regulator, whose functions would be affected by the proposed order. The consultation will provide the regulator and industry with an opportunity to make their views known. That point was pursued by the noble Lord, Lord Bradshaw. I hope that he is satisfied on that, and that it is absolutely clear.
	The results of this consultation will influence both the Minister and Parliament in reaching a decision on the content of the draft order and the appropriate level of Parliamentary scrutiny of it. The results will also influence whether Parliament wishes to approve the order, or whether it exercises its right to veto it.
	Furthermore, the preconditions in the Bill and the statutory consultation provisions are not requirements for making primary legislation, the availability of which, in itself, does not lead to regulatory uncertainty or act as an obstacle to private investment. The procedural and substantive safeguards for any order should provide the reassurance that economic regulators and their respective markets need that changes to the regulatory structure cannot be made on a whim. In addition to that certainty, the Government have said throughout the parliamentary passage of this Bill that it is not our intention to erode the independence from the Government of those regulators set up by statute. I hope that that reassures the two noble Baronesses who have pursued that point.
	This House will, of course, also be aware of the Government's undertaking not to deliver highly controversial proposals by order. If a Minister decided to pursue an order in the face of vocal and evidence-based opposition from a regulator—or, indeed, from the regulated, whom we must not forget—this undertaking would also influence whether Parliament wished to approve the order or whether it chose to exercise its right to veto it. In addition to the protections provided in the Bill, I reiterate that businesses that are being regulated must have the right to raise concerns if economic regulators are carrying out their functions, for instance, overly bureaucratically. If there are sound reasons for suggesting any modification of their statutory functions for the purposes of removing or reducing burdens, or of modifying how those functions are carried out, it should be possible to address these by order, as it would be possible for any other regulator. I ask noble Lords why we should not seek to make that distinction. There should be a level playing field.

Lord Norton of Louth: My Lords, Amendments Nos. 23 and 24 are consequential. We discussed in Committee the extent to which order-making powers could be used to impose or repeal penalties involving fines and imprisonment. I expressed the view that we had to be circumspect in providing that any body other than Parliament itself could prescribe specified offences carrying terms of imprisonment. I tabled amendments designed to limit the scope for imposing or repealing penalties carrying terms of imprisonment.
	I listened carefully to what the Minister had to say in response. My amendment takes account of what he said. I have decided not to pursue amendments affecting the repeal or modification of existing offences. I can see that there may be a case for retaining those powers in order to remove burdens, but I do not consider that approach the best one. I would have preferred the proposal advanced by my noble friend Lord Goschen; namely, that of an annual deregulation Bill, a medium through which offences could, with Parliament's assent, be removed or created. However, if we are to have this Bill, I am prepared to concede the power to modify or remove existing offences.
	I think, though, that there remains a case for requiring primary legislation for new offences. My amendment provides that no new offences may be created under Part 1, and that the penalty for existing offences may not be increased so that they are punishable on indictment for a term exceeding two years, or on summary conviction imprisonment for a term exceeding the normal maximum term or a fine exceeding level 5 on the standard scale.
	The case for the amendment is straightforward. New offences, especially those carrying terms of imprisonment, should be introduced through primary legislation and subject to the full rigours of legislative scrutiny. There is greater scope for probing and considering amendments than is the case with the order-making power. Parliament needs to be at its most rigorous and operating in the full glare of public attention when it introduces new offences that may result in individuals being sent to prison.
	What, then, is the argument for allowing new offences to be created by secondary legislation? In Committee, the Minister argued that a new offence would be subject to the safeguard that Ministers would need to ensure that the preconditions in Clause 3 were met, and that the order could be vetoed by the relevant parliamentary Committee. He also pointed out that the provision was carried over from the 2001 Act, and that the provision had not been abused.
	Those arguments are not sufficient to overcome the point of principle in question. The fact that a provision is carried over from the 2001 Act is not, to my mind, a commendation, as I variously argued on other points earlier today. I was as critical of that measure as I am of this one. The Minister's own words could be used against him. To claim that the provision has not been abused is to concede that it could be.
	In essence, the choice is between a point of principle and one of convenience. We may be willing to concede that burdens including criminal sanctions may be removed by secondary legislation and that existing sanctions may be modified, but I think we should be extremely wary of permitting, or continuing to permit, the creation of new sanctions by secondary legislation. I beg to move.

Lord Bassam of Brighton: My Lords, Amendment No. 22 and its consequential Amendments Nos. 23 and 24 seek, as the noble Lord described, to prevent any order from creating any new criminal offence.
	Taken in isolation, I could understand that the powers to create new offences might raise some concerns. However, the creation of a new criminal offence by order could not be done arbitrarily. This ability is entirely limited by the vires of the order-making powers so that criminal offences could only be created by order for the purposes of either Clause 1 or Clause 2; that is, they would have to be for the purpose of removing or reducing a burden for any person or securing that regulatory functions are exercised in accordance with the principles of better regulation. In an order made under Clause 1, the creation of a new offence would have to be for the purpose of removing or reducing a burden defined, for example, as a financial cost, an administrative inconvenience, an obstacle to productivity, profitability or efficiency or, most importantly, perhaps, in this context, an existing sanction.
	Furthermore, the provisions in Clause 1 provide a power to remove or reduce burdens resulting from existing legislation and could not be used to create entirely new regimes. They could, however, be used to replace one statutory regime with another that is less burdensome for any person. In such cases, there might be an existing criminal offence which is no longer considered to be well targeted. This may be, for example, because it applies to too wide a category of situations or persons. The order might then contain provision to replace the existing criminal offence with a new narrow one which was felt to be better focused, where this was for the purpose of reducing or removing the burden of the existing wider criminal offence.
	One of the key problems with the 2001 Act is that it contained a number of arbitrary technical restrictions. This prevented proposals from being implemented in perhaps the most logical way. In some cases, the restrictions formed such a barrier that it did not make sense to deliver the proposal by order, delaying or preventing, in our view, the delivery of better regulation. We need to avoid creating new technical restrictions, particularly regarding sanctions, which form a major part of ensuring compliance and hence the success of a regulatory regime.
	The powers to create new criminal offences provided for in the Bill are not unprecedented. As noted in Committee, this power has parallels in the European Communities Act and as the noble Lord, Lord Norton of Louth, has observed, was carried over from the 2001 Act. I know he does not accept the point, but that is the case.
	Clause 6 also specifies the limits on the level of sanctions that may be imposed. These are less than those already contained in a number of regulatory regimes, so the maximum levels in Clause 6 set meaningful limitations to this power. Furthermore, the Government have already made a commitment not to deliver highly controversial proposals by order. Proposals which create inappropriate new criminal offences will clearly come into that category, so that is the limiting effect of our commitment.
	In addition, the pre-conditions in Clause 3 prevent a Minister from making an order which he considers, among other things, to remove necessary protections or to prevent anyone from continuing to exercise any right or freedom which they might reasonably expect to retain. This opinion would have to take account of any representations received during the statutory public consultation period and would be scrutinised by parliamentary committees which have the power, as we have explained on many occasions, to veto any proposal they consider unsuitable for delivery by order.
	I understand where the noble Lord is coming from. I know that he will not find it easy to accept the constraints which we argue we have put in place because he thinks we should do this through primary legislation, but I would invite him to consider that we have provided real constraints and a narrowing. I hope he will recognise that this is a practical measure and will withdraw his amendment.

Lord Goodhart: My Lords, this debate has seen three alternatives proposed, each of which has merits and is arguably an improvement on the present situation in the Bill. Having said that, I recognise that Clause 15 of the Bill allows either House to require that anything introduced under either the negative or the affirmative resolution procedure can be upgraded as a result of the decision of either House of Parliament. That being so, the difference between what has been proposed in this group of amendments and the Bill as it now stands is fairly narrow. Under those circumstances, I beg leave to withdraw the amendment.

Lord Bassam of Brighton: My Lords, I always admire the telegraphic style of the noble Lord, Lord Kingsland. It is most helpful on this occasion.
	Before I turn to this specific amendment, it may assist the House if I first address some confusion about the interpretation of the Human Rights Act that arose in Committee. As your Lordships will be aware, the Human Rights Act gives effect in our law to rights drawn from the European Convention on Human Rights; those rights are known as the convention rights. Section 6(1) of the Act makes it unlawful for a public authority to act in a way which is incompatible with the convention rights. A Minister of the Crown is a public authority for those purposes and is therefore bound to act compatibly with the convention rights when discharging his or her duties. Parliament is, however, expressly excluded from being a public authority by virtue of Section 6(3).
	When a Minister seeks to make secondary legislation, whether under the Bill or otherwise, he is therefore legally required to do so compatibly with the convention rights because secondary legislation is made by Ministers and scrutinised by Parliament, rather than being made by Parliament itself. If secondary legislation is not compatible with the convention rights, the court may strike it down, as it would if the Minister had acted ultra vires in any other way in making it. Your Lordships will, of course, know that the Human Rights Act does not allow a court to strike down primary legislation; instead, a court may draw incompatible primary legislation to Parliament's attention by means of a declaration of incompatibility.
	The noble Lord, Lord Goodhart, drew attention in Committee to a provision in Section 21 of the Human Rights Act under which secondary legislation that amends primary legislation is treated as primary legislation for the purposes of the Act. However, if one looks to see where the distinction between primary legislation and secondary legislation arises in the Act, one finds that it has a bearing only on the remedies available to the court should it find the secondary legislation incompatible. In particular, the distinction does not arise in Section 6 and therefore does not change the position that a Minister who makes incompatible secondary legislation is acting unlawfully.
	I know that we will come later to the noble Lord's other amendment, which would make it possible for a court to strike down all secondary legislation made under this Bill, whether or not it amends primary legislation. However, even without that amendment, the position remains under the Human Rights Act that it is not unlawful for a Minister to make secondary legislation that is incompatible with the convention rights.
	This amendment would require that all secondary legislation made under this Bill would have to be accompanied by a statement of compatibility, similar to the Section 19 statement that appears on the front of every Government Bill presented to the House. In nearly every case—including this Bill—this is a statement of compatibility under Section 19(1)(a) of the Human Rights Act. It certifies that, in the opinion of the Minister in charge of the Bill, its provisions are compatible with the convention rights.
	It is possible for a Minister to make an alternative statement under Section 19(1)(b) of the Human Rights Act. Such a statement indicates that, although the Minister cannot make a statement of compatibility, the Government nevertheless wish the House to proceed with the Bill.
	The Section 19 statement reflects an important distinction under the Human Rights Act: that Parliament is still permitted to act incompatibly with the convention rights. Noble Lords will note that Parliament is expressly excluded from being a public authority in section 6(3) of the Human Rights Act.
	It is, however, proper that if the Government are going to ask Parliament to legislate incompatibly, we should be absolutely clear when doing so, which is the point of the Section 19 statement. The option to act incompatibly does not arise for secondary legislation, as I have explained. Therefore, the statement of compatibility with which the Government accompany certain secondary legislation as a matter of convention when it is being scrutinised by Parliament serves only to confirm that the Minister considers the instrument to be compatible. It would, therefore, already be unlawful for the Minister to make secondary legislation that is incompatible.
	If a Minister were to indicate that proposed secondary legislation is not compatible with the convention rights, he would effectively be admitting that he was intending to act unlawfully in making it. It is for that reason that I must oppose the noble Lord's amendment. The Government would not, and could not, lawfully make orders under this Bill or any other Act that are incompatible. However, providing in statute for a statement similar to Section 19 could wrongly give the impression that the genuine alternative of acting incompatibly is open to the Minister.
	I hope that I have explained clearly why the Government cannot support the amendment. They will continue as a matter of convention to make such statements, but we would oppose any move to require this in statute for the reasons I have given. I hope that the noble Lord, having followed that, will withdraw his amendment.

Viscount Colville of Culross: My Lords, with this amendment I am returning to a point that I raised in Committee. I think the noble Lord, Lord McKenzie of Luton, who dealt with it on that occasion, will probably concede that no very careful consideration was given to the points that I raised, but that has now been repaired. Nevertheless, I must set out my stall. I appreciate that all those noble Lords who have not already caught their trains home are dying to do so, but I must try to set out the problem so that the House can understand what I am talking about.
	The problem concerns the formulation of criminal offences which arise out of the transposition of European instruments into British law. Let me give an example of this. Under instrument 1228 of this year—which covers the very important subject of transmissible spongiform encephalopathy—where any premises are occupied and licensed, an occupier commits an offence if he maintains and operates the premises other than in accordance with,
	"the requirement of the Community TSE Regulation and these Regulations"—
	and there are some fairly substantial penalties.
	How do you comply with the requirements of the Community TSE regulations? The instrument earlier states:
	"Expressions that are not defined in these Regulations and occur in the TSE Community Regulation",
	have the same meaning here as they do there.
	So what is the TSE regulation? It is contained in a schedule and consists of a list of 27 different instruments which have emerged from the European Commission over a period of time, some of them quite recent but many of the amending others. Nowhere in the regulation is there a definition of the offence, simply that you can fail to comply with it.
	The Bill is about transparency and reducing burdens, and, under the terms of the Bill, "burdens" include criminal sanctions. It is ordinary good sense that people should understand what they are forbidden to do. I think it is also in accordance with Article 7 of the European Convention on Human Rights that they should know this. There has, however, occurred a massive practice of simply transposing European regulations without ever saying what they mean and what are the offences created under them.
	I have been very worried about this. I have been sitting on the Merits Committee for some time and British regulations after regulations occur where we have exactly this problem. I was greatly relieved to find that I am not alone in being upset about this. In the Third Report of the Joint Committee on Statutory Instruments in 2001, the committee, which, of course, contains members of this House and another place, concluded that in its view the regulation it was considering—it was in exactly the same form as the one I have been talking about—was not consistent with the United Kingdom's traditional legislative practice of precision in the formulation of criminal offences, and it reported that provision for defective drafting. But nothing has been done and the situation continues as before. When we asked in the committee why this was so, one of the answers was that "because EU Regulations"—the TSE one was a regulation,
	"are directly applicable in law in all countries, normal drafting practice is to avoid repetition of EU regulations provisions in domestic legislation, as it may result in duplication or in the meaning of effect of the Regulations being obscured".
	I doubt whether it could be much more obscure than it is at the moment.
	That is not true. I am talking in particular about Defra regulations but this applies to other departments as well. Some other regulations were recently produced by Defra where exactly the opposite of what I have just read out has been applied. SI 2005/3522 related to the disposal of older cattle and slaughterhouses. I drew it to the noble Lord's attention in Committee but he did not comment on it. In the schedule is a parallel set of columns. The first refers to the provision of the Commission regulation that the SI is referring to, while the second contains the subject matter of the offence that will be committed if you do not pay attention to it. So it is not true that you do not put into the British regulation some indication of what you must do to avoid getting into trouble.
	There was another very good example in SI 2006/1970 relating to sea fisheries. Here is a whole collection of requirements, again relating to a Council regulation about fishing, fines, and so on. There are three columns: the first refers to the provision of the regulation; the second refers to the subject matter of the offence which you would commit if you were not careful; and in the third column is a very large sum which you are liable to by way of a fine if you offend. That comes from the same department which said it was impossible to put this into British regulations. There they are. As I said, it is not simply Defra which does this; a number of other departments, including the DTI, do the same.
	We do not comply with the transparency provisions underlined by the Bill and we do not comply with the reduction of sanctions in the term of what constitutes a criminal offence underlined by the Bill. The noble Lords, Lord McKenzie of Luton and Lord Bassam, have taken a good deal of trouble to have a meeting with me and to discuss these points with officials, and I am very grateful to both of them. I am told that they do not like my amendment. Well, there is nothing new in that, is there? What amendment has ever been liked by Government? Nevertheless, I think they concede that there is a point. I see them nodding, which means that perhaps there is a point.
	The noble Lords have suggested that this problem should go to the review being carried out by the noble and learned Lord, Lord Davidson of Glen Clova, which is to report very soon. I was today given the consultation documents that have so far emerged. This is primarily concerned with that very eminent topic, gold plating, and its two close friends, double banking and regulatory creep. I do not think that the terms of reference are entirely apt to deal with what I am talking about, but there is a passage that gives me a little cause for encouragement.
	The noble and learned Lord refers to the tradition of precise drafting, aimed at reducing uncertainty in this country, and contrasts it with a more purposive approach adopted by the legal systems of some continental member states as well as by the European Commission, which broadly speaking deals in civil law rather than common-law terms, and the methods with which we are familiar in this country.
	If the Minister is going to say that he does not like my amendment, I shall not be surprised, but something here needs to be attended to. It is not just businesses and charitable and voluntary organisations which are affected by these rules; it is also individuals We cannot have a situation where a farmer confronted with this kind of regulation would have to spend a great deal of time looking up, for instance, 27 different European instruments on the internet, if they have it and are able to use it, and then see whether what they were doing complied.
	This approach has been criticised also by those whom we in the committee have in our turn criticised as being faulty because what is done in this country might not be the same as what is done in other European states. A recent example in the latest report of the Merits of Statutory Instruments Committee will come before your Lordships, and some noble Lords might like to think about it.
	An ancient, 1985 directive relates to uncultivated land, and doing things to it to make it cultivated, as well as to restructuring projects. Nothing in the European legislation defines either "uncultivated land" or "restructuring projects". Therefore, some time ago—I think it was in 2001—the Government introduced an uncultivated land provision by way of statutory instrument and laid down a threshold of two hectares. If you carry out operations on that land, you are in for trouble. There was an instance of somebody who spread lime on an environmentally sensitive piece of grassland in York and was heavily fined for doing so. There is no threshold that I know of in any other European country which is the equivalent of two hectares.
	Then, quite apart from that, the statutory instrument examined in the latest Merits Committee report introduces the restructuring programme. Nobody knows what "restructuring" means. Nobody knows what area it relates to, and Defra has made up the rules—they may be very sensible. They relate to the things that "restructuring" may convey. However, all I can tell your Lordships is that our rules are seriously different in extent from those in Ireland, Belgium and the Netherlands. It is therefore no use saying that, because the offences are not specified, we are liable to get into trouble by not conforming to what is happening in the rest of the European Union—we are already doing so.
	What is going to be done about this? If the Minister does not like my amendment, he must first of all assure me that the noble and learned Lord, Lord Davidson, will be able to deal with this point, because I doubt that it is within his terms of reference. If he is not, the Cabinet Office will have to provide instructions to parliamentary clerks in various government departments on how to draft regulations. They are going to have to pay attention to what the Joint Committee said five or six years ago. If they do not, we will not be sticking to the precepts that underline this Bill—transparency, and the removal of sanctions. This is an occasion when we must really emphasise that government departments should pay attention to this problem. It is no use leaving it on the basis that you can look it all up on the internet or find some other method of dealing with it.
	The other thing that the Joint Committee said was, "Oh, well, it's always covered by guidance". So it is, but guidance does not do any good in a criminal court, nor does a criminal court have access to the guidance. Indeed, I do not think that the criminal court has access to the European legislation either. When I used to sit at Harrow, there was no indication in the library of the official journal in which one could look all those things up, and I very much doubt whether it would have been readily obtainable by me as a judge. Goodness knows what is going to happen to the clerks to magistrates' courts when they are confronted with this—because that is where the majority of the cases are going to go.
	There are provisions which apply the prohibitions with a sanction that includes prison. I very much trust that that is not the course that will be taken. Fines are much more likely to be effective. Nevertheless, somebody has to impose the fine and find out what offence is alleged to have been committed. So ought people be able to find out what the offence is before they decide whether they are going to commit it. That is one of the basic principles of criminal law in this country. I beg to move.

Lord Kingsland: My Lords, that slightly complicates what I intended to say. The report of the noble and learned Lord, Lord Davidson, is about gold-plating, which is a function of directives, not regulations. As I understand it, regulations are instruments that, when issued on a certain date by the European Community, are required henceforth to be obeyed in each one of the member states. Directives, by contrast, are given typically 18 months or two years before implementation has to take place, and thereafter the member Government are not obliged to implement the directive word for word, as long as they reconstitute the objective behind the directive in their national regulations. In so far as the noble Viscount is talking about regulations, it seems to me that the committee of the noble and learned Lord, Lord Davidson, is entirely inappropriate to deal with the matter.
	Regulations are not supposed to be amplified or altered in any way by a member state once made by the European Community; but, in the context of what the noble Viscount has been saying, we are in difficulty with regulations that subsequently become the subject of national criminal law. That goes to the heart of the point he is trying to make. The European Community has no authority over the making or implementation of criminal law.
	We are in particular difficulties over this point in relation to Article 7 of the European Convention on Human Rights. That article requires the definition of any criminal offence to be sufficiently specific that an individual can assess whether the activity he is about to enter into is capable of constituting a criminal act. As the noble Viscount pointed out, regulations are drafted in many different languages, and they do not define the particular legislative target in a way that fits in with our criminal law—or, in particular, our criminal evidence system—at all. On the Continent, they have the inquisitorial approach to crime: no juries, judges with immense power to investigate the background as well as the specifics of the alleged offence, and burdens and standards of proof that sometimes differ dramatically from our own. It is almost impossible to discern, in a regulation that is intended subsequently to be applied by the criminal law, the traditional approaches of our courts even to such fundamental distinctions as mens rea and actus reus.
	Both for Article 7 reasons, and because the Continental systems are so different from our own, in my judgment there is a really compelling case here to follow the line suggested by the noble Viscount. Of course, as he rightly says, one of the ways Governments escape from amendments tabled by your Lordships' House is to look at the detail of the amendment and explain why the detail is not quite right, thus avoiding having to confront the principle. However, what matters here is not the detail but the principle. We want to know from the Government whether they accept that principle. I am sure we are going to hear from the Minister why the particular detail that the noble Viscount has set out does not quite fit the bill.
	We all owe the noble Viscount a great debt for raising this serious matter. If it is not confronted by the Government now, sooner or later we will find Article 7 points taken, and the Government will not be able to say in those circumstances that they have not been warned.

Lord McKenzie of Luton: My Lords, I add my genuine thanks to the noble Viscount, Lord Colville of Culross, for his diligence and persistence on this issue and for the useful examples of good and bad practice which he brought to our attention in Committee and again today. I readily acknowledge that we did not seek to answer the point that he raised in Committee, but I hope that what has happened in the interim, and what will happen, will demonstrate that the Government take this matter seriously and that there is an effective way forward.
	The purpose and effect of Amendment No. 36 are very similar to those of the amendment that the noble Viscount tabled in Committee. As he explained then, the amendment would make it possible to tell, by reading UK legislation alone, without the need to cross-refer to the relevant Community legislation, what one is obliged to do and what one must not do to avoid committing a criminal offence. He said that this was a question of transparency and reducing the burden for those who have to deal with statutory instruments that transpose European Community obligations into domestic law. These are issues which the Government take extremely seriously.
	The Government agree with the intention behind the noble Viscount's amendment and that every effort should be made to ensure that European Community obligations are transposed into domestic law in a way that is transparent and reduces the burden on those dealing with them. He was also right in saying that Defra tries to address that by including in some statutory instruments a schedule to explain those provisions in the relevant European directive that, should they be breached, will amount to an offence under domestic law. The two examples of SI 2006/1970 on sea fisheries and 2005/3522 on the disposal of older cattle were cited by the noble Viscount in Committee and again today. He also referred to those instruments as examples of good practice.
	The Government will continue to seek ways to ensure that all statutory instruments that transpose European Community obligations into domestic law are drafted in a manner that is clear, simple and transparent. Although I agree with the intention of the noble Viscount's amendment, as he has anticipated we cannot support it today. Current drafting guidance does not explicitly state whether a description of an offence should be included in an SI used to transpose a European Community obligation, or how detailed any such description should be. Instead, departments are given the flexibility to decide on a case-by-case basis how best to draft an SI that transposes a Community obligation. Amendment No. 36 would remove this flexibility by requiring all subordinate legislation used to transpose European Community obligations into domestic law to include a description of any activity which, if carried out, would constitute a criminal offence.
	Although I cannot support Amendment No. 36, I can assure the noble Viscount that the Government will consider the points that he has made today. Clearly, one route is through the guidance given to departmental lawyers who draft the implementing Community obligations, which seems an appropriate way of encouraging best practice. We will certainly look at that to see how it might be strengthened to address the point that the noble Viscount made.
	There was some discussion about the committee of the noble and learned Lord, Lord Davidson. It is right, as the noble Lord, Lord Kingsland, said, that it focuses primarily on gold-plating issues, which are about directives and not regulations. However, the review is about considering the implementation of EU legislation, and we will ensure that the noble and learned Lord, Lord Davidson, who is undertaking the review of implementation of European Union legislation, receives for his consideration copies of Hansard for the debates today and in Committee, as well as the examples of best practice that the noble Viscount provided. We will also seek to facilitate his own direct engagement with that process, if he so wishes. I hope that, in that manner, we can move the issue forward.
	I hope that the noble Viscount will accept that the Government are committed to finding means of transposing European Community obligations into domestic law in a way that is transparent and reduces the burden on those required to comply with European Union directives. For example, they are exploring the possibility of making consolidated versions of statutory instruments used to implement Community obligations into domestic law publicly available. The Davidson review has taken note of these representations. It is likely that the review will recommend that consolidated versions of statutory instruments should be made publicly available. The Government also stated in their response to the Merits of Statutory Instruments Committee's 29th Report of Session 2005-2006 that they will dedicate resources to formally and "informally"—that is, without making a new instrument—consolidating statutory instruments where departmental Ministers can identify appropriate cases. This intention is consistent with the Government's simplification programme, which requires departments to consider whether they can reduce the regulatory burdens which fall on business, the voluntary sector and front-line public servants by providing greater clarity on the content or interpretation of legislation.
	I am conscious that my response has not provided a precise way of dealing specifically with the important point that the noble Viscount has again raised, but I hope that, through the mechanisms and processes that I have mentioned, there is a way forward and that we can achieve the objective he so rightly pursues. On that basis I hope that he will withdraw the amendment.

Viscount Colville of Culross: My Lords, I am entirely in favour of consolidation; there is too little of it at the moment, and it would be a great help if it were available in some shape or form. I dare say that it will be on the website but, never mind, that is better than nothing.
	I thank the noble Lords, Lord Desai and Lord Kingsland, for their support. It does not matter whether it is a regulation or a directive, the trouble in the transposition arises in exactly the same way. In neither case does the parliamentary Clerk—or not usually—put into the British statutory instrument anything which says what the offence is. I am very glad that I was supported by the noble Lord, Lord Kingsland, on Article 7 of the European convention. I believe that that is at the heart of the matter. It is not right that people should not be able to discover—or at any rate without the most colossal trouble—what they are not allowed to do, which is subject to criminal sanctions. It certainly is not transparent.
	I will happily talk to the noble and learned Lord, Lord Davidson, about this. If he is concerned only with directives, we will have to deal with that, but it does not matter very much, as this involves both sorts of European instruments are involved. I hope that these two short debates will ensure that somebody in the Cabinet Office will tell parliamentary Clerks that there is good practice. I have given two examples of it, and the noble Lord has acknowledged that. I tried to do that in Committee but it was brushed aside as being perfectly hopeless, airy-fairy and nothing other than confusing. However, that does not seem to be the case, as sometimes, but by no means always, parliamentary Clerks continue to put summaries of the offence in schedules. Why can't we have a new instruction across the board that that should always be done? Then someone has, at any rate, the beginning of an idea where to look for the actions that they must avoid if they are not to get into trouble. If that is what the noble Lord is telling me he will set afoot, I will not return to the matter. However, I promise him that the reports of the Merits of Statutory Instruments Committee will continue to look at this. It has not gone away and there is no sign whatever of it improving as a result of anything that has been said.
	Please, look again at what the Joint Committee said in 2001 and see whether something can be done about it. The noble Lord nods his head and I am sure that he will probably get something done. I hope that he may communicate with me a little further before Third Reading next week—it is also on a Thursday, so I shall be in the same trouble as I am today.

Lord Kingsland: My Lords, I emphasise at the outset that this amendment is not about the content of the directives themselves. They raise a range of issues that are of great importance but form no part of this matter. The Cassis de Dijon case, decided in the late 1980s, and the White Paper of the noble Lord, Lord Cockfield, which came a few years later, got the Community off to a good start in pursuing its objective of a single market. I think your Lordships will agree that, since then, the results have been like the curate's egg. I am in no doubt that it will not be long before one or other of your Lordships will again be drawing to our attention matters about the contents of the directives.
	The noble and learned Lord, Lord Davidson, has been conducting an inquiry about gold-plating, the background to the issue that this amendment attempts to raise; and we applaud that. It is somewhat surprising that it has taken the Government nine and a half years to get down to studying this issue, because concerns about gold-plating have been expressed at least since the mid or late 1980s; and, to be fair to the Government, my own party did not address this issue when it was in Government.
	I hope that I will be forgiven for being uncharacteristically cynical in seeking a reason for the reluctance of both Governments to look at the issue. Community legislation gets on to the statute book very easily in this country because directives are introduced through Section 2 of the European Communities Act 1972; that section requires only an Order in Council for the legislation to be made. None of the legislation goes through the elaborate process that primary legislation has to go through in your Lordships' House and another place.
	The framework for everything that has been done in the world of Community directives starts with essentially unscrutinised legislation; and that breeds a morass of regulation that is equally unscrutinised, because the only thing that your Lordships' House and another place can do is to adopt it or refuse it, on a take-it-or-leave-it basis. This is very attractive to officials and Ministers for obvious reasons: partly because they are not obliged to defend their case against the Opposition in Parliament, and partly because they can make wide-ranging decisions about how the British economy should work, without having to clutter up the annual demands for primary legislation or queue for it. So we get a disproportionately large amount of Community legislation on the statute book because it is very easy to get it there. The other reason is that civil servants—in many cases, no doubt, for very good reasons—have been aching to get matters on to the statute book for years and years but have never succeeded in the annual bid for primary legislation. So they tend to add on to a directive a whole range of purely domestic matters for which they could find no happy legislative home at an earlier stage.
	I commend the Government on having had the courage at last to come out of the closet on this issue and on inviting the noble and learned Lord, Lord Davidson, to look at it, in a sense, at a stage removed from Government and to come up with some sensible answers. We applaud the establishment of the Davidson committee, but we feel that we are entitled to ask the Government: why nine and a half years? After all, their task force has been going for almost the same length of time as the Government. If they were so enthusiastic about deregulation, one would have thought that they would have confronted the issue of gold-plating head-on earlier. However, we are all looking forward, as I suppose the Government are, to the noble and learned Lord's conclusions.
	As I understand it, one technique used by the noble and learned Lord, Lord Davidson, in his investigation is to talk to government departments and non-governmental agencies in other member states, which are recognised as having a lighter regulatory touch than ours, to see whether a similar approach would be acceptable in the UK. If that is what the noble and learned Lord has, in fact, done, I find that enormously refreshing. First, by doing so, the Government—or, at least, the noble and learned Lord, Lord Davidson—are accepting that some other nation states apply a lighter touch than us. That, in itself, is good reason for conducting his investigation. But I very much hope that in his report he will give a full account of the work done in this area.
	From what has appeared so far on the noble and learned Lord's website, the questions that he is asking seem pertinent and, in some cases, rather penetrating. His general approach is to ensure that, in future, UK business will not be disadvantaged when competing with businesses in other euro states because of regulatory burdens. I believe that that principle lies behind his investigation. I think that he focuses particularly on whether the implementing measures widen the scope of the original directives. That is a very important area of investigation. You might argue that a directive needs to be elaborated in a certain way because we have law in this country that does not derive from the Community but presents a problem for implementation in exactly the way that the directive suggests. However, I do not think that there is any case for domestic legislation to widen the scope of a directive. That goes to my earlier point about some departments using Community directives to get in purely domestic issues for which they cannot find a primary legislative home.
	There are one or two other matters that the noble and learned Lord wisely included in his terms of reference. He asks, for example, whether the UK is really taking full advantage of any derogations in the EU measure, and if not, why not. There are wide-ranging derogations in directives simply because member states negotiate hard, and one of the ways for the Community to end up legislating is by making concessions to such member states. They are not described as concessions to Lithuania, the UK or France; they appear on the face of the directive as derogations—sensible conclusions that all 25 states, or however many there are in the European Community these days, agree with.
	The noble and learned Lord will also concentrate on whether enforcement mechanisms themselves, or the sanctions imposed, go beyond the minimum necessary. That matter will be plainly in his sights, as indeed it is in the Bill.
	One task that the noble and learned Lord has given himself, which I also find most interesting, is to look at the risks that the Government thought required a measure of gold-plating at the outset—when the directive was implemented—and to assess whether these risks today are still as apparent and of as much concern as they were then. I think that he will ask government departments to address the issue with great particularity.
	In the context of the Bill, it seems that the noble and learned Lord's investigation is absolutely central. That is why I tabled my amendment. I sense that the Government will say, "Well, thank you very much for saying that the Davidson committee has been set up, but, unfortunately, we will not know what it says until long after the Bill leaves your Lordships' House. Of course, we cannot be absolutely certain that his conclusions will comply with the absolutist tone of your directive. Therefore, let's wait and see what the noble and learned Lord says, and the issue can then be addressed on some subsequent occasion".
	I shall be very interested to hear what the Minister says in reply. I might be quick-footed enough, if I think there is some weight in what the Government say, to change my amendment before Third Reading, but I am not inclined to let this go if the Government turn me down at this stage. I beg to move.

Lord McKenzie of Luton: My Lords, the purpose of this amendment appears to be to introduce a legislative barrier to gold-plating European Community obligations when they are transposed into domestic law through secondary legislation.
	As the Government have stated throughout the debate on this Bill, we take the issue of gold-plating and the over-implementation of European Community obligations extremely seriously, and we are taking action to deal with the concerns of business on that. The review that the noble and learned Lord, Lord Davidson of Glen Clova, is conducting for the Government, for instance, is specifically aimed at identifying examples where it is clear that Community obligations have been over-implemented. Where necessary, the review will consider ways of reducing the regulatory burdens imposed on business by the existing stock of legislation implementing Community obligations. I presume that the noble Lord has seen a copy of the interim report of the review, which gives an update on progress. The hope is that the report will now be concluded quite quickly.
	It has always been the Government's policy to implement European Community obligations so as to achieve the objectives of the obligation without over-implementation. The Cabinet Office guidance on the transposition of European directives makes it explicitly clear that only in certain exceptional circumstances and where it is justified by a robust cost/benefit analysis and extensive consultation with stakeholders should departments consider implementation that goes beyond the minimum required by a European directive. The guidance also makes it clear that all decisions to implement beyond the minimum required by a European directive must be made public.
	The effect of the amendment would be to preclude any discretion on the part of any Government in the transposition of EC obligations into domestic law by statutory instrument. Is the intention of the noble Lord, Lord Kingsland, really to further limit the discretion of any UK Government to implement Community obligations in a way that best suits the particular circumstances of the UK? I cannot believe that that is his aim.
	The interim report of the noble and learned Lord, Lord Davidson, provides a number of specific examples where the noble Lord's proposed amendment would have precluded the Government from acting in the UK's best interests. The evidence demonstrates that, by implementing European Community obligations in a way that goes beyond the minimum required by a European directive, the Government can ensure that directives are implemented in line with domestic legislation, meet the UK's higher standards and reflect the specific requirements of the UK.
	For example, when transposing the temporary work at height directive, the Government extended the scope so that it applied to the self-employed in domestic legislation—something I hope that we all support. By extending the scope of this directive, the Government ensured that it maintained the UK's higher standards, in line with the provisions of the Health and Safety at Work etc. Act 1974, which pre-dated the EC legislation by 17 years. This ensures equal protection for those who might be injured by people working at heights, regardless of whether the person is self-employed or an employee, and prevents unscrupulous contractors from escaping their health and safety duties by claiming that their employees are self-employed. Were this amendment on the statute books when the directive was transposed into domestic legislation, the Government would have had to accept the lower standards of health and safety set by the EC. This would also have caused unnecessary confusion and inconsistency between similar businesses.
	A further example is the 2003 prospectus directive. In this case, representatives of the financial services industry commented that this was an example where the Treasury and the Financial Services Authority had engaged with stakeholders early on and, on industry advice, had taken sensible decisions to maintain higher UK standards than the EC directive prescribed so as to provide higher consumer protection and financial stability. The UK financial markets are the leading markets in the EU and, therefore, changing their regulatory practices to tie in with rules appropriate to less advanced markets may have undermined the UK's position.
	The amendment would present further problems when transposing Community obligations into domestic law. It would require that, in implementing a Community obligation, the Government do not impose or increase any burden that is,
	"not necessary to implement the Community obligation or right".
	However, it is often impossible to tell, or at least to agree, the bare minimum necessary to implement a Community obligation. The wording of EU directives is sometimes vague and the Government have to make a risk-based judgment about how the European Court of Justice might interpret the wording in question. This amendment would handicap the Government in their attempts to do that and would be likely to lead to numerous challenges in the UK courts by bodies asserting that the Government were going further than necessary. Ultimately, that would use up time and resources and place UK courts in the very difficult position of having to try to second-guess what the European Court of Justice might rule.
	I suggest that the provisions in the Bill are, in fact, better placed to respond effectively and pragmatically to the issues of gold-plating and over-implementation than the noble Lord's amendment. That is because Clause 1 can be used to remove or reduce a burden, which could, in principle, include removing or reducing a burden resulting from implementation of an EC directive that goes beyond the minimum required. Furthermore, the provisions of Clause 20 make it possible to combine an order made under Section 2(2) of the European Communities Act 1972 with an order made under the Bill to remove or reduce burdens. That will enable a single order to implement Community law under Section 2(2) of the ECA and remove pre-existing domestic statutory provisions that have been superseded by Community law using the power in Clause 1. That will help to reduce occurrences of double-banking.
	Given the undesirable restrictions that this amendment would impose, I urge the noble Lord to withdraw it.

Lord McKenzie of Luton: My Lords, I thank the noble Lord for those questions. I will try to answer them as best I can. The guidance is a document which changes from time to time to deal with changing circumstances. Indeed, in our earlier debate we touched on how it might be used as the mechanism to deal with the point raised by the noble Viscount, Lord Colville.
	Part of that guidance requires the regulatory impact assessment to be produced when transposition takes place. That sets out the analysis that must be undertaken. The guidance is on the Cabinet Office website; all departments are aware of it; it is updated regularly; and it is expected that it would be complied with. If the noble Lord is unable to access it readily, perhaps he will let me know and I should be happy to provide him with a copy and the documentation that surrounds it.
	On the European Court of Justice, under the proposed amendment legislation cannot be introduced in the UK that is not absolutely necessary to implement a Community obligation or right. If, under the drafting of that Community obligation or right, there is uncertainty about what it might mean, when it is transposed into UK legislation there would be a risk—would there not?—that somebody could come along and say that this is doing more than is absolutely necessary. Therefore, there is another area for contention about how that legislation is introduced. I think that that is the key point.
	We read the amendment as precluding dealing with social aspects of legislation. It seemed to me to be an absolute issue—that you should not do anything that was not absolutely necessary to implement the Community obligation. One would think that that would mean that, other things being equal, if there were a range of dates for its implementation you would have to introduce it at the latest period that you possibly could because it would be doing more than was necessary to do so earlier—for example, where you would have to take advantage of all the derogations. How would that impact on what is proposed?
	The issue of timing and some of these points are touched upon in the interim report of my noble and learned friend Lord Davidson. That might be worth a review. I hope that I have dealt with the key points the noble Lord has raised. If not, I will try again.

Lord Kingsland: My Lords, I do not propose to return to the question of the interpretation of the European Court of Justice or of social legislation. Suffice it to say that, if social legislation deriving from purely domestic measures sets higher standards than those in the directive, my amendment would not affect those social rules, which derive from purely domestic legislation. It would therefore in no way inhibit the United Kingdom from having higher standards than those in the directive.
	I quite take the point about the possibility of measures for a directive that go wider than the terms of the directive widening the risk of references to the European Court of Justice. However, when we are talking about domestic rules—purely community regulations rather than the directives themselves, because the directives must always be implemented in some form—I was concerned to underline the principle of the last word on the interpretation of a directive or directive-derived legislation always being with the European Court of Justice.
	I am most grateful to the Minister. I have found these exchanges very useful, both because the noble and learned Lord, Lord Davidson, will not report until long after the Bill is put to bed and because the Minister has given me an idea or two in the context of the Cabinet guidance. I shall not return at Third Reading with this amendment, but I might return with a more nuanced attempt to have some reference to this very important subject put into the Bill. Meanwhile, I beg to ask leave to withdraw the amendment.

Lord Bassam of Brighton: My Lords, the reference to the Church of England in the Bill was inserted in recognition of its particular constitutional position, rather than because it was a religious institution or organisation. The noble Lord may not have been present when I moved the relevant amendment in Committee; I cannot recall. The long-standing convention is that the Government will not legislate on anything within the competence of the Church of England, which has de facto delegated power, without the agreement of the Church.
	Such agreement takes different forms depending on the circumstances. Concerns were expressed about the ability to use the order-making powers in the Bill to legislate in a way that affected the Church's functions without having to obtain its consent. The Government took these concerns to heart and proposed an amendment to Clause 32, which was approved by your Lordships' House. The clause was amended to fulfil the Government's obligation under the convention, and ensures that the powers under Clause 2 and Part 2 will not apply to the regulatory activities of bishops, church courts and disciplinary tribunals or to the legislative role of the General Synod, where it passes legislation that has a regulatory effect.
	The noble Lord's amendment raises other issues and, despite the reasonable intentions behind it, we cannot agree that it should be included. The Church of England has a unique constitutional position with Parliament and the passing of legislation in relation to it. Other religious organisations in the UK do not have similar standing and there is no precedent for treating these organisations in the same way, which probably answers both questions posed by the noble Lord.
	Whether this position in relation to religious organisations is correct or wrong in principle is, I would argue, not the subject of this Bill. For the purpose of ensuring that the Bill remains focused on better regulation, I would also say that it is not a subject for this House today. Perhaps I should also point out that the amendment does not attempt to define a religious organisation, so perhaps it does not fall into that trap. There is no agreed definition of the term in English law. If the amendment were agreed, there would of course be a whole host of arguments about whether a particular body fell within the terms of the definition. The noble Lord could stir up something of a hornets' nest if he wanted to. I hope that that satisfies the noble Lord.

Baroness Wilcox: My Lords, this is possibly the final amendment—so it will be welcome in that regard. It would ensure that any standing orders brought under this Bill will have enough time to be sufficiently considered before they are put into force. This Bill will come into force at the beginning of January, very soon after Parliament returns from the Christmas Recess. Any standing orders that the Government wish to implement immediately will have only one month of sitting parliamentary time to be debated and agreed. Clearly, that is not enough time for effective scrutiny.
	I understand that the Government do not intend to make any orders until March 2007, which would allow the Procedure Committee enough time to finish its work and for Parliament to consider the orders to be agreed on. However, if no orders are to be made until March, why will the Bill come into force so long before? Surely it would be more sensible for the Bill's commencement date to be delayed until all the loose ends are tied up, which would also give us some much-needed reassurance that the Government intend to implement this legislation in a considered manner after it has been properly scrutinised. I beg to move.

Lord Bassam of Brighton: My Lords, I am pleased to hear the noble Baroness at the Dispatch Box. We have not heard enough of her. It saddens me greatly that we have now reached the last amendment and are hearing from her only for the second time.
	The noble Baroness of course makes a valid argument. I understand the concern that the time available for parliamentary committees to consider revising orders perhaps is not as she would wish. Obviously, we want to ensure that we have in place a good working system for scrutinising orders when new orders are put to committees under the Bill. We agree that engaging parliamentary committees on revisions to standing orders is essential to that process. But I come back to the point that the amendment seeks only to delay the Bill, which is unnecessary, because that work can continue.
	We have said here and in another place that we want to work with committees to ensure that amendments to standing orders are in place, and we have delivered on that commitment. Throughout the passage of the Bill through Parliament, we have provided relevant committees of both Houses with opportunities to consider and share their views on those amendments. Working drafts of the new orders informed by continuing discussions have been shared with the committee chairs, and official drafts will be issued in time for Third Reading. The progress on this dialogue to date indicates that a formal extension of the Bill is not necessary.
	I give a commitment that we will continue to work with committees to ensure that they are aware of the timetable for laying orders and have sufficient warning of any approaching work. We think there will be an opportunity for continued discussion after Royal Assent and before orders are laid under the terms of this Bill. I am grateful to the noble Baroness for the amendment, but we do not think it is necessary. I therefore invite her to withdraw it.